Specialist - DQA, CDMO Biologics

Development Quality Assurance (DQA) - Biologics

Experience: 10+ Years

Role Summary:

Provide quality oversight for Biologics development activities and ensure compliance with GMP, regulatory requirements, and internal quality systems.

Key Responsibilities:

• Review and approve analytical and process development documents.
• Review method validation, process validation, technology transfer, deviations, CAPAs, and change controls.
• Ensure compliance with FDA, EMA, ICH, and GMP requirements.
• Support audits, inspections, and quality risk management activities.
• Work closely with Analytical Development, Process Development, Manufacturing, and Regulatory Affairs teams.

Qualifications:

• M.Sc./Ph.D. in Biotechnology, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field.
• 10+ years of experience in Development QA/Quality Assurance within Biologics/Biosimilars.
• Strong experience in analytical and process document review.
• Good understanding of biologics development, GMP, and global regulatory requirements.